Transthyretin Cardiac AmyloidosisPhase 1/2FIDTCANCT07835880
[18F]FIDT-10b PET Imaging in Cardiac Amyloidosis
A Phase 1/2 study testing [18F]FIDT-10b and 99mTc-PYP in people with Transthyretin Cardiac Amyloidosis and Light Chain Cardiac Amyloidosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a first in human study that will assess the safety, pharmacokinetics, biodistribution and diagnostic performance of [18F]FIDT-10b (fluorine-18 labeled FIDT-10b), a positron emission tomography (PET) agent. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transthyretin Cardiac Amyloidosis, Light Chain Cardiac Amyloidosis
- What is being tested?
- [18F]FIDT-10b and 99mTc-PYP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For part 1 and 2:
- must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
- Only for part 1:
- For ATTR-CA participants:
- males or females: age 18-90 years
- with a confirmed diagnosis of ATTR-CA by standard criteria
Show all 15Show fewer
- For AL-CA participants:
- males or females: age 18-80 years
- with a confirmed diagnosis of AL-CA by standard criteria
- For healthy participants:
- males or females: age 18-80 years
- no cardiac-related diseases
- Only for part 2:
- males or females: age 18-90 years
- suspected or confirmed ATTR-CA
Who cannot join
- For part 1 and 2:
- pregnancy or breastfeeding
- severe claustrophobia
- inability or refusal of consent
- any condition deemed by the investigator to interfere with study results or increase participant risk
- Only for part 1:
Show all 17Show fewer
- For ATTR-CA participants:
- non-ischemic cardiomyopathy due to other causes of myocardial hypertrophy
- diagnosis of primary or secondary AL-CA
- contraindications for MRI (eGFR<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for MRI)
- For AL-CA participants:
- co-diagnosis of multiple myeloma, Waldenström macroglobulinemia, or other lymphoproliferative disorders
- For healthy participants:
- any cardiac-related diseases based on medical history and corresponding clinical evaluations, including electrocardiography, echocardiography, and laboratory tests
- Only for part 2:
- non-ischemic cardiomyopathy due to other causes of myocardial hypertrophy
- contraindications for MRI (eGFR<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for MRI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, 100730
Peking Union Medical College Hospital, +86 69156874, pumchkyc@126.com
About this study
Official title: Safety, Biodistribution, Dosimetry and Diagnostic Performance of [18F]FIDT-10b in Healthy Subjects and Patients With Cardiac Amyloidosis
This is a first in human study that will assess the safety, pharmacokinetics, biodistribution and diagnostic performance of [18F]FIDT-10b (fluorine-18 labeled FIDT-10b), a positron emission tomography (PET) agent. This agent has the potential to specifically identify the involved myocardium of patients with transthyretin cardiac amyloidosis (ATTR-CA).
Read the detailed description
Light chain cardiac amyloidosis (AL-CA) and transthyretin cardiac amyloidosis (ATTR-CA) are the two leading causes of cardiac amyloidosis with tremendous impact on patients. Regardless of the underlying cause, the clinical course of cardiac amyloidosis ultimately culminates in impaired cardiac function resulting from amyloid deposition, manifesting as infiltrative cardiomyopathy, conduction abnormalities, and cardiac sympathetic and parasympathetic denervation. These cardiac functional impairments are irreversible. Therefore, early etiological diagnosis and effective therapeutic intervention prior to the progress of severe cardiac dysfunction are importance.
There is an urgent need for non-invasive, sensitive, accurate, and visualizable approaches for the diagnosis and subtyping of cardiac amyloidosis. Current guidelines recommend bone scintigraphy for the non-invasive diagnosis of ATTR-CA, with a diagnostic specificity exceeding 90% but a sensitivity of only approximately 71%, raising the possibility of missed diagnosis or delayed diagnosis in a subset of patients. This has further propelled the development of PET molecular probes that specifically target amyloid proteins.
The investigators have preclinical data demonstrating that [18F]FIDT-10b selectively binds to ATTR deposits with high affinity in vitro via a combination of intermolecular forces, including van fer Waals forces, hydrophobic- hydrophobic interactions, π-π stacking, and hydrogen bonds, with the β-sheet architecture, supporting its potential utility for specific imaging of affected myocardium in patients with ATTR-CA. The investigators propose that this agent has significant potential for clinical translation. This first-in-human study is designed to evaluate the safety, pharmacokinetics, biodistribution in patients with cardiac amyloidosis and healthy participants (Part 1), and diagnostic performance of [18F]FIDT-10b in individuals with suspected or confirmed ATTR-CA (Part 2). This study will provide critical insights into the performance of [18F]FIDT-10b PET imaging as a potential non-invasive imaging tool for the detection of ATTR-CA and compared with routine clinical 99mTc-PYP SPECT imaging.
- Being tested
- [18F]FIDT-10b, 99mTc-PYP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FIDT-10bDrug
An I.V. bolus injection of up to 10 millicurie (mCi) [18F]FIDT-10b will be administered, followed by a PET/CT scan.
[18F]FIDT-10bDrug
An I.V. bolus injection of up to 10 millicurie (mCi) [18F]FIDT-10b will be administered, followed by a PET/CT or PET/MRI scan.
[18F]FIDT-10bDrug
An I.V. bolus injection of up to 10 millicurie (mCi) [18F]FIDT-10b will be administered, followed by a PET/CT scan.
99mTc-PYPDrug
An I.V. bolus injection of up to 30 millicurie (mCi) 99mTc-PYP will be administered, followed by a SPECT planar and SPECT/CT scan.
[18F]FIDT-10bDrug
An I.V. bolus injection of up to 10 millicurie (mCi) [18F]FIDT-10b will be administered, followed by a PET/CT or PET/MRI scan.
99mTc-PYPDrug
An I.V. bolus injection of up to 30 millicurie (mCi) 99mTc-PYP will be administered, followed by a SPECT planar and SPECT/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| Part 1-Dosimetry and Proof of Concept Study-Cohort A | Experimental | Healthy participants receive [18F]FIDT-10b for PET imaging. Receives: Drug: [18F]FIDT-10b |
| Part 1-Dosimetry and Proof of Concept Study-Cohort B | Experimental | ATTR-CA participants receive [18F]FIDT-10b for PET imaging to see how the drugs work in the myocardium. Receives: Drug: [18F]FIDT-10b; Drug: 99mTc-PYP |
| Part 1-Dosimetry and Proof of Concept Study-Cohort C | Experimental | AL-CA participants receive [18F]FIDT-10b for PET imaging to see how the drugs work in the myocardium. Receives: Drug: [18F]FIDT-10b |
| Part 2-Diagnostic Performance Study | Experimental | Suspected or confirmed ATTR-CA participants receive [18F]FIDT-10b for PET imaging to explore the potential diagnostic performance and additional value of 99mTc-PYP scintigraphy. Receives: Drug: [18F]FIDT-10b; Drug: 99mTc-PYP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability evaluation (Part 1)
The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
Measured: Within 30 days following PET imaging
Focal or diffuse myocardial lesions of ATTR-CA identified with [18F]FIDT-10b PET imaging (Part 2)
The reference standard comprised biopsy-proven extracardiac amyloidosis or pathogenic TTR mutation on genetic testing, in both cases accompanied by typical cardiac imaging appearance; a positive endomyocardial biopsy also served as an independent reference standard.
Measured: Through study completion, an average of 3 months
Secondary outcomes (5)
Radiation Dosimetry of [18F]FIDT-10b
OLINDA/EXM will be used to determine the absorbed dose and effective dose per individuals.
Measured: Through study completion, an average of 3 months
Biodistribution of [18F]FIDT-10b
At different time points after drug injection, perform PET/CT whole-body scans to obtain radioactivity counts in major irradiated organs at each phase, reflecting the drug's biodistribution in the body.
Measured: Through study completion, an average of 3 months
Identify the ideal time point for imaging after [18F]FIDT-10b injection
Left ventricular myocardial lesion to-blood pool background ratios as a function of time will be measured. The time point resulting in optimal lesion-to-background ratios, taking into account a realistic implementation in clinical practice, will be defined as the ideal time point for imaging.
Measured: Through study completion, an average of 3 months
Diagnostic performance of [18F]FIDT-10b for ATTR-CA
Assessment of the sensitivity and specificity of PET imaging with [18F]FIDT-10b for the diagnosis of ATTR-CA based on visual and semi-quantitative scan interpretation.
Measured: Through study completion, an average of 3 months
Preliminary assessment of lesion targeting by [18F]FIDT-10b as compared to 99mTc-PYP
Detection rate of visual interpretation will be performed to compare the number of detected lesions using both tracers.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835880
- Sponsor's protocol ID
- FIDTCA
- Acronym
- FIDTCA
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Biodistribution, Dosimetry and Diagnostic Performance of [18F]FIDT-10b in Healthy Subjects and Patients With Cardiac Amyloidosis
- ClinicalTrials.gov ID
- NCT07835880
- Acronym / sponsor ID
- FIDTCA / FIDTCA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first in human study that will assess the safety, pharmacokinetics, biodistribution and diagnostic performance of [18F]FIDT-10b (fluorine-18 labeled FIDT-10b), a positron emission tomography (PET) agent. This agent has the potential to specifically identify the involved myocardium of patients with transthyretin cardiac amyloidosis (ATTR-CA).
Detailed description
Light chain cardiac amyloidosis (AL-CA) and transthyretin cardiac amyloidosis (ATTR-CA) are the two leading causes of cardiac amyloidosis with tremendous impact on patients. Regardless of the underlying cause, the clinical course of cardiac amyloidosis ultimately culminates in impaired cardiac function resulting from amyloid deposition, manifesting as infiltrative cardiomyopathy, conduction abnormalities, and cardiac sympathetic and parasympathetic denervation. These cardiac functional impairments are irreversible. Therefore, early etiological diagnosis and effective therapeutic intervention prior to the progress of severe cardiac dysfunction are importance.
There is an urgent need for non-invasive, sensitive, accurate, and visualizable approaches for the diagnosis and subtyping of cardiac amyloidosis. Current guidelines recommend bone scintigraphy for the non-invasive diagnosis of ATTR-CA, with a diagnostic specificity exceeding 90% but a sensitivity of only approximately 71%, raising the possibility of missed diagnosis or delayed diagnosis in a subset of patients. This has further propelled the development of PET molecular probes that specifically target amyloid proteins.
The investigators have preclinical data demonstrating that [18F]FIDT-10b selectively binds to ATTR deposits with high affinity in vitro via a combination of intermolecular forces, including van fer Waals forces, hydrophobic- hydrophobic interactions, π-π stacking, and hydrogen bonds, with the β-sheet architecture, supporting its potential utility for specific imaging of affected myocardium in patients with ATTR-CA. The investigators propose that this agent has significant potential for clinical translation. This first-in-human study is designed to evaluate the safety, pharmacokinetics, biodistribution in patients with cardiac amyloidosis and healthy participants (Part 1), and diagnostic performance of [18F]FIDT-10b in individuals with suspected or confirmed ATTR-CA (Part 2). This study will provide critical insights into the performance of [18F]FIDT-10b PET imaging as a potential non-invasive imaging tool for the detection of ATTR-CA and compared with routine clinical 99mTc-PYP SPECT imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1-Dosimetry and Proof of Concept Study-Cohort A | Experimental | Drug: [18F]FIDT-10bHealthy participants receive [18F]FIDT-10b for PET imaging. |
| Part 1-Dosimetry and Proof of Concept Study-Cohort B | Experimental | Drug: [18F]FIDT-10b, Drug: 99mTc-PYPATTR-CA participants receive [18F]FIDT-10b for PET imaging to see how the drugs work in the myocardium. |
| Part 1-Dosimetry and Proof of Concept Study-Cohort C | Experimental | Drug: [18F]FIDT-10bAL-CA participants receive [18F]FIDT-10b for PET imaging to see how the drugs work in the myocardium. |
| Part 2-Diagnostic Performance Study | Experimental | Drug: [18F]FIDT-10b, Drug: 99mTc-PYPSuspected or confirmed ATTR-CA participants receive [18F]FIDT-10b for PET imaging to explore the potential diagnostic performance and additional value of 99mTc-PYP scintigraphy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
- males or females: age 18-90 years
- with a confirmed diagnosis of ATTR-CA by standard criteria
- males or females: age 18-80 years
- with a confirmed diagnosis of AL-CA by standard criteria
Key exclusion criteria (17 listed)
- pregnancy or breastfeeding
- severe claustrophobia
- inability or refusal of consent
- any condition deemed by the investigator to interfere with study results or increase participant risk
- non-ischemic cardiomyopathy due to other causes of myocardial hypertrophy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FIDT-10bAn I.V. bolus injection of up to 10 millicurie (mCi) [18F]FIDT-10b will be administered, followed by a PET/CT scan. | Drug | Part 1-Dosimetry and Proof of Concept Study-Cohort A |
| [18F]FIDT-10bAn I.V. bolus injection of up to 10 millicurie (mCi) [18F]FIDT-10b will be administered, followed by a PET/CT or PET/MRI scan. | Drug | Part 1-Dosimetry and Proof of Concept Study-Cohort B |
| [18F]FIDT-10bAn I.V. bolus injection of up to 10 millicurie (mCi) [18F]FIDT-10b will be administered, followed by a PET/CT scan. | Drug | Part 1-Dosimetry and Proof of Concept Study-Cohort C |
| 99mTc-PYPAn I.V. bolus injection of up to 30 millicurie (mCi) 99mTc-PYP will be administered, followed by a SPECT planar and SPECT/CT scan. | Drug | Part 1-Dosimetry and Proof of Concept Study-Cohort B |
| [18F]FIDT-10bAn I.V. bolus injection of up to 10 millicurie (mCi) [18F]FIDT-10b will be administered, followed by a PET/CT or PET/MRI scan. | Drug | Part 2-Diagnostic Performance Study |
| 99mTc-PYPAn I.V. bolus injection of up to 30 millicurie (mCi) 99mTc-PYP will be administered, followed by a SPECT planar and SPECT/CT scan. | Drug | Part 2-Diagnostic Performance Study |
Primary outcome
Safety and tolerability evaluation (Part 1)
Time frame: Within 30 days following PET imaging
The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
Focal or diffuse myocardial lesions of ATTR-CA identified with [18F]FIDT-10b PET imaging (Part 2)
Time frame: Through study completion, an average of 3 months
The reference standard comprised biopsy-proven extracardiac amyloidosis or pathogenic TTR mutation on genetic testing, in both cases accompanied by typical cardiac imaging appearance; a positive endomyocardial biopsy also served as an independent reference standard.
5 secondary outcomes
Radiation Dosimetry of [18F]FIDT-10b
Time frame: Through study completion, an average of 3 months
Biodistribution of [18F]FIDT-10b
Time frame: Through study completion, an average of 3 months
Identify the ideal time point for imaging after [18F]FIDT-10b injection
Time frame: Through study completion, an average of 3 months
Diagnostic performance of [18F]FIDT-10b for ATTR-CA
Time frame: Through study completion, an average of 3 months
Preliminary assessment of lesion targeting by [18F]FIDT-10b as compared to 99mTc-PYP
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. Available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [18F]FIDT-10b and 99mTc-PYP in people with Transthyretin Cardiac Amyloidosis and Light Chain Cardiac Amyloidosis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Huo (+86 18612672038, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability evaluation (Part 1) (time frame: Within 30 days following PET imaging). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.